Cardium Announces FDA 510(K) Clearance of InnerCool's RapidBlue(TM) Endovascu...( SAN DIEGO Oct. 20 /- Cardium Ther...)

SAN DIEGO, Oct. 20 /PRNewswire-FirstCall/ -- Cardium Therapeutics (Amex: CXM) and its operating unit InnerCool Therapies, Inc., announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the RapidBlue(TM) System, an endovascular temperature modulation device. InnerCool's RapidBlue System is a thermal regulating system designed to manage and control patient body temperature. This new system automatically cools or warms patients, as necessary, to quickly and controllably achieve and then maintain a desired body temperature. RapidBlue provides rapid or gradual temperature control for all patient sizes. Its closed loop catheter-based system modulates whole body temperature, without fluid introduction or exchange, by circulating cool or warm saline within the interior of the catheter. RapidBlue is powerful enough to quickly cool awake patients and may eliminate the need to use paralytic agents. The system combines a high-performance programmable console with an enhanced user-friendly interface.

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"The FDA's 510(k) clearance of our new RapidBlue endovascular system represents a key milestone in completing Cardium's turnaround and strategic repositioning of our InnerCool investment. We believe that the new RapidBlue System is the most powerful and easiest to use endovascular-based system in the world and is the only endovascular temperature modulation system that has obtained both U.S. FDA and European CE mark regulatory clearances as well as UL certification, providing InnerCool with one of many competitive advantages," stated Ch
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